FDA Label for Milk Of Magnesia
View Indications, Usage & Precautions
Milk Of Magnesia Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
saline laxative/antacid
Distributed by:
VistaPharm, Inc.
Largo, FL 33771, USA
Distributed by:
Cardinal Health
Dublin, OH 43017
L55273200419
VP2152R1
09/17
Otc - Purpose
Active Ingredient
(in each 5 mL = 1 teaspoonful)
Magnesium Hydroxide.................400 mg
Inactive Ingredients
anhydrous citric acid, benzyl alcohol, methylparaben, propylene glycol, propylparaben, purified water.
Indications
Uses
• For relief of occasional constipation (irregularity)• This product generally produces bowel movement in 1/2 to 6 hours.• heartburn• sour stomach• acid indigestion• and upset stomach associated with these symptoms
Uses
For the relief of
Warnings
Ask a doctor before use if you have
• kidney disease• a magnesium-restricted diet• stomach pain, nausea, or vomiting• a sudden change in bowel habits that lasts more than 2 weeks• presently taking a prescription drug. This product may interact with certain prescription drugs.• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.• you need to use a laxative for more than 1 week• kidney disease• a magnesium-restricted diet• presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician
May have laxative effect
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• shake well before use• drink a full glass (8 oz) of liquid with each dose• mL = milliliter• The dose may be taken as a single daily dose or in divided doses.• shake well before use• mL = milliliter• adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician• do not take more than 12 teaspoonfuls (60 mL) in 24-hour period• do not use the maximum dosage for more than 2 weeks• children under 12 years: consult a physician
Adults and children 12 years of age and older | 30 mL to 60 mL |
Children 6 to 11 years of age | 15 mL to 30 mL |
Children under 6 years of age | Consult a physician. |
or as directed by a physician.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
How Supplied
Milk of Magnesia USP 400 mg/5 mL is a white opaque liquid supplied as follows:
Overbagged with 5 x 30 mL unit-dose cups per bag, NDC 55154-4061-5
Storage
Other Information
• Protect from freezing• Store at 20° to 25°C (68° to 77°F)
Questions Or Comments?
Call 1-888-655-1505 (toll-free)
Principal Display Panel
Milk of Magnesia, USP 2400 mg
of Magnesium Hydroxide per 30 mL
5 Cups
* Please review the disclaimer below.